The Safe Harbor Provision of 35 U.S.C. § 271(e)(1) states that:
“It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention (other than a new animal drug or veterinary biological product which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site-specific genetic manipulation techniques) solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.”
In a recent infringement case, Amgen v. Hospira, the allegedly infringed patents related to cells that stimulate the creation of red blood cells in anemia patients and a method of preparing erythropoietin (EPO).
In 2001, the U.S. Patent and Trademark Office (USPTO) issued a written description guideline in which it specified that one of skill in the art would have recognized that the spectrum of antibodies which bind to antigen X were implicitly disclosed as a result of the isolation of antigen X.
In a recent case, Idenix Pharmaceutical LLC v. Gilead Sciences Inc. (Fed. Cir. 2019), the Federal Circuit affirmed a decision from the District Court invalidating a patent for lack of written description and enablement.
A few weeks ago (mid-October 2019), the USPTO released an updated (view here) patent subject matter eligibility guidance (PEG) along with new examples related to personalized medicine, therapeutic methods, and pharmaceutical products.
The October update is essentially a clarification of the January 2019 guidance.
Finally, a few diagnostic method claims have been found patent eligible. This is not a Court decision, but rather a decision reached by the Patent Trial and Appeal Board (PTAB). The claims under the PTAB were:
Recently, in Mayo Foundation for Medical Education and Research v. Iancu, the Federal Circuit agreed with the U.S. Patent and Trademark Office (USPTO) with regard to the Patent Term Adjustment (PTA) for U.S. Patent No. 8,981,063. The issue was whether the interpretation of “any time consumed by continued examination of the application requested by the applicant” was correct.
In two recent cases, the Federal Circuits held that claim amendments at issue were “tangential” to the “equivalent” at issue, and upheld findings of infringement.
The case details are below:
Case #1: Ajinomoto Co. v. ITC
The claim amendment at issue related to an encoding nucleotide sequence. The original claim language recited “a protein which comprises an amino acid sequence including deletion, substitution, insertion or addition of one or several amino acids in the amino acid sequence shown in SEQ ID NO:2,” and was replaced with “a protein which comprises an amino acid sequence that is encoded by a nucleotide sequence that hybridizes with the nucleotide sequence of SEQ ID NO:1 under stringent conditions.”
The Federal Circuit agreed with ITC’s determination that the amendment was “tangential” to the equivalent at issue based on the following:
The rationale for the amendment was to limit the set of proteins claimed so that it no longer included a protein found in the prior art and was not related with choosing among several DNA sequences in the redundant genetic code that correspond to the same protein.
Thus, according to the Federal Circuit, prosecution history estoppel did not bar application of the doctrine of equivalents.
Case #2: Eli Lilly and Co. v. Hospira, Inc.
During prosecution, the language of administering “pemetrexed sodium” was amended to administering “an antifolate” to distinguish the claims from a prior art reference.
The accused products contained pemetrexed ditremethamine, not pemetrexed sodium, but the Federal Circuit found that the amendment was “tangential” to the equivalent, and thus prosecution history estoppel did not apply.
The amendment was not related to the type of salt, thus, the applicant did not surrender other pemetrexed salts.
Even if within these cases it was possible to find infringement under the doctrine of equivalents, it should be kept in mind that where the reason for the amendment and the equivalent in question both relate to the same claim element, the tangential exception does not apply.
The United States Patent and Trademark Office (USPTO) has proposed to modify the fees associated with all aspects of patent filing and maintenance. The proposal includes an increase — by about 25% — of the petition fees and institution fees for all post-grant proceedings.
Post-Grant Proceeding Fee Increases
The total fees due will bring the total costs to:
$40,000+ for an Inter Partes Review (IPR); and
$50,000+ for Post Grant Review (PGR) or Covered Business Method (CBM).
A petition challenging more than 20 claims will increase by approximately 25%
Non-registered patent attorney admitted to practice before the PTAB will have to pay a new $250 “pro hac vice” fee.
Issue Fee Increases
Issue fees will increase to $1,200;
the 3.5 year maintenance fees will increase to $2,000;
the surcharge will increase to $500.
These are the applicable large entity fees. Small entity fees will be 50% of the above.
Other Fee Increases
The fee for requesting expedited examination of a design application will increase to $2,000 for a large entity.
If a utility application is not filed in DOCX format, the USPTO will issue a new charge of $400.
This slide deck (USPTO.gov) explains the proposal in further detail. Please note that written comments regarding these fee increases are due to the USPTO by September 30, 2019.
These increases have been justified to enhance the quality and timeliness of patent prosecution. Another reason why the USPTO proposed these fee increases is to replenish the USPTO coffers, since patent application filings had decreased, perhaps due to the difficulties generated by the recent U.S. Supreme Court on subject matter eligibility?
Nuvo Pharmaceuticals, Inc. v. Dr. Reddy’s Laboratories, Inc. is an interesting case, recently decided by the Federal Circuit. The claims at issue were directed to a pharmaceutical composition of a non-steroidal anti-inflammatory drug (NSAID) coated with a proton pump inhibitor (PPI). The aim of the invention was to provide a formulation of a NSAID which did not provoke bleeding in the stomach.